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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
510(k) Number K101853
Device Name PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115
Applicant
Diadexus, Inc.
343 Oyster Pt. Blvd.
South San Francisco,  CA  94080
Applicant Contact NINA PELED
Correspondent
Diadexus, Inc.
343 Oyster Pt. Blvd.
South San Francisco,  CA  94080
Correspondent Contact NINA PELED
Regulation Number866.5600
Classification Product Code
NOE  
Date Received07/01/2010
Decision Date 01/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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